Identity
- Trade Name
- ENDURE INDUSTRIES FDA UDI
- Generic Name
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
- Device Name
- Endure Sutures NYLON, Blue, 16mm, 3/8 PRC, 45cm, 4-0 FDA UDI
- Model / Reference
- EN46163-45 FDA UDI
- Description
- Endure Sutures NYLON, Blue, 16mm, 3/8 PRC, 45cm, 4-0 FDA UDI
Identifiers
- Catalog Number
- EN46163-45 FDA UDI
- Primary DI / UDI-DI
- 00840118613057 FDA UDI
- 510(k) Number
- K080684 FDA UDI
- FDA Product Code
- GAT FDA UDI
- GMDN Term
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nylon suture, non-bioabsorbable, monofilament
Endure Industries by Endure Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nylon suture, non-bioabsorbable, monofilament.
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- Henry Schein — HENRY SCHEIN, INC. · Class II
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- SUPRAMID — S. Jackson, Inc. · Class II
- ETHILON — Ethicon Inc. · Class II
- UNIFY Nylon Surgical Sutures — APPLIED DENTAL, INC. · Class II
- DemeLON — DemeTECH Corp · Class II
Cleared under the same submission
K080684 also covers:
- UNIFY Nylon Surgical Sutures — APPLIED DENTAL, INC.
- Oasis — American Health Service Sales Corporation
- Blue Sky Bio, LLC. — BLUE SKY BIO LLC
- WEGO-Nylon Non-absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc.
- WEGO-Nylon Non-absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc.
- WEGO-Nylon Non-absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc.
- WEGO-Nylon Non-absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc.
- WEGO-Nylon Non-absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc.
- WEGO-Nylon Non-absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc.
- WEGO-Nylon Non-absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc.
- WEGO-Nylon Non-absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc.
- WEGO-Nylon Non-absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Endure Industries, Inc.
Sources (1)
- FDA UDI 713b5136-35bf-42c4-ab53-bc5d209543bb 37 fields · synced Jun 1, 2026